
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC341]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                           SUBCHAPTER IV--FOOD
 
Sec. 341. Definitions and standards for food

    Whenever in the judgment of the Secretary such action will promote 
honesty and fair dealing in the interest of consumers, he shall 
promulgate regulations fixing and establishing for any food, under its 
common or usual name so far as practicable, a reasonable definition and 
standard of identity, a reasonable standard of quality, or reasonable 
standards of fill of container. No definition and standard of identity 
and no standard of quality shall be established for fresh or dried 
fruits, fresh or dried vegetables, or butter, except that definitions 
and standards of identity may be established for avocadoes, cantaloupes, 
citrus fruits, and melons. In prescribing any standard of fill of 
container, the Secretary shall give due consideration to the natural 
shrinkage in storage and in transit of fresh natural food and to need 
for the necessary packing and protective material. In the prescribing of 
any standard of quality for any canned fruit or canned vegetable, 
consideration shall be given and due allowance made for the differing 
characteristics of the several varieties of such fruit or vegetable. In 
prescribing a definition and standard of identity for any food or class 
of food in which optional ingredients are permitted, the Secretary 
shall, for the purpose of promoting honesty and fair dealing in the 
interest of consumers, designate the optional ingredients which shall be 
named on the label. Any definition and standard of identity prescribed 
by the Secretary for avocadoes, cantaloupes, citrus fruits, or melons 
shall relate only to maturity and to the effects of freezing.

(June 25, 1938, ch. 675, Sec. 401, 52 Stat. 1046; Apr. 15, 1954, ch. 
143, Sec. 1, 68 Stat. 54; Aug. 1, 1956, ch. 861, Sec. 1, 70 Stat. 919; 
Pub. L. 103-80, Sec. 3(h), Aug. 13, 1993, 107 Stat. 776.)


                               Amendments

    1993--Pub. L. 103-80 substituted ``or reasonable standards of fill 
of container. No definition'' for ``and/or reasonable standards of fill 
of container: Provided, That no definition''.
    1956--Act Aug. 1, 1956, designated provisions constituting subsec. 
(a) as entire section and repealed subsec. (b) which provided the 
procedure for establishment of regulations and is covered by section 
371(e) of this title.
    1954--Act Apr. 15, 1954, designated existing provisions as subsec. 
(a) and added subsec. (b).


                            Savings Provision

    Section 3 of act Aug. 1, 1956, provided that: ``In any case in 
which, prior to the enactment of this Act [Aug. 1, 1956], a public 
hearing has been begun in accordance with section 401 of the Federal 
Food, Drug, and Cosmetic Act [341 of this title] upon a proposal to 
issue, amend, or repeal any regulation contemplated by such section, or 
has been begun in accordance with section 701(e) of such Act [section 
371(e) of this title] upon a proposal to issue, amend, or repeal any 
regulation contemplated by section 403(j), 404(a), 406(a) or (b), 
501(b), 502(d), 502(h), 504 or 604 of such Act [section 343(j), 344(a), 
346(a) or (b), 351(b), 352(d), 352(h), 354, or 364 of this title], the 
provisions of such section 401 or 701(e), as the case may be, as in 
force immediately prior to the date of the enactment of this Act [Aug. 
1, 1956], shall be applicable as though this Act [amending this section 
and section 371(e) of this title] had not been enacted.''

                          Transfer of Functions

    For transfer of functions of Federal Security Administrator to 
Secretary of Health, Education, and Welfare [now Health and Human 
Services], and of Food and Drug Administration in the Department of 
Agriculture to Federal Security Agency, see note set out under section 
41 of this title.

         Ex. Ord. No. 13100. President's Council on Food Safety

    Ex. Ord. No. 13100, Aug. 25, 1998, 63 F.R. 45661, provided:
    By the authority vested in me as President by the Constitution and 
the laws of the United States of America, and in order to improve the 
safety of the food supply through science-based regulation and well-
coordinated inspection, enforcement, research, and education programs, 
it is hereby ordered as follows:
    Section 1. Establishment of President's Council on Food Safety. (a) 
There is established the President's Council on Food Safety 
(``Council''). The Council shall comprise the Secretaries of 
Agriculture, Commerce, Health and Human Services, the Director of the 
Office of Management and Budget (OMB), the Administrator of the 
Environmental Protection Agency, the Assistant to the President for 
Science and Technology/Director of the Office of Science and Technology 
Policy, the Assistant to the President for Domestic Policy, and the 
Director of the National Partnership for Reinventing Government. The 
Council shall consult with other Federal agencies and State, local, and 
tribal government agencies, and consumer, producer, scientific, and 
industry groups, as appropriate.
    (b) The Secretaries of Agriculture and of Health and Human Services 
and the Assistant to the President for Science and Technology/Director 
of the Office of Science and Technology Policy shall serve as Joint 
Chairs of the Council.
    Sec. 2. Purpose. The purpose of the Council shall be to develop a 
comprehensive strategic plan for Federal food safety activities, taking 
into consideration the findings and recommendations of the National 
Academy of Sciences report ``Ensuring Safe Food from Production to 
Consumption'' and other input from the public on how to improve the 
effectiveness of the current food safety system. The Council shall make 
recommendations to the President on how to advance Federal efforts to 
implement a comprehensive science-based strategy to improve the safety 
of the food supply and to enhance coordination among Federal agencies, 
State, local, and tribal governments, and the private sector. The 
Council shall advise Federal agencies in setting priority areas for 
investment in food safety.
    Sec. 3. Specific Activities and Functions. (a) The Council shall 
develop a comprehensive strategic Federal food safety plan that contains 
specific recommendations on needed changes, including measurable outcome 
goals. The principal goal of the plan should be the establishment of a 
seamless, science-based food safety system. The plan should address the 
steps necessary to achieve this goal, including the key public health, 
resource, and management issues regarding food safety. The planning 
process should consider both short-term and long-term issues including 
new and emerging threats and the special needs of vulnerable populations 
such as children and the elderly. In developing this plan, the Council 
shall consult with all interested parties, including State and local 
agencies, tribes, consumers, producers, industry, and academia.
    (b) Consistent with the comprehensive strategic Federal food safety 
plan described in section 3(a) of this order, the Council shall advise 
agencies of priority areas for investment in food safety and ensure that 
Federal agencies annually develop coordinated food safety budgets for 
submission to the OMB that sustain and strengthen existing capacities, 
eliminate duplication, and ensure the most effective use of resources 
for improving food safety. The Council shall also ensure that Federal 
agencies annually develop a unified budget for submission to the OMB for 
the President's Food Safety Initiative and such other food safety issues 
as the Council determines appropriate.
    (c) The Council shall ensure that the Joint Institute for Food 
Safety Research (JIFSR), in consultation with the National Science and 
Technology Council, establishes mechanisms to guide Federal research 
efforts toward the highest priority food safety needs. The JIFSR shall 
report to the Council on a regular basis on its efforts: (i) to develop 
a strategic plan for conducting food safety research activities 
consistent with the President's Food Safety Initiative and such other 
food safety activities as the JIFSR determines appropriate; and (ii) to 
coordinate efficiently, within the executive branch and with the private 
sector and academia, all Federal food safety research.
    Sec. 4. Cooperation. All actions taken by the Council shall, as 
appropriate, promote partnerships and cooperation with States, tribes, 
and other public and private sector efforts wherever possible to improve 
the safety of the food supply.
    Sec. 5. General Provisions. This order is intended only to improve 
the internal management of the executive branch and is not intended to, 
nor does it, create any right or benefit, substantive or procedural, 
enforceable at law by a party against the United States, its agencies, 
its officers or any person. Nothing in this order shall affect or alter 
the statutory responsibilities of any Federal agency charged with food 
safety responsibilities.
                                                     William J. Clinton.

                  Section Referred to in Other Sections

    This section is referred to in sections 337, 343, 343-1, 350, 371 of 
this title.
